Airway Inflammation Among Workers in the Silicon Carbide Processing Industry

NCT01337180 | Withdrawn DMC

• 1 other identifier: 5690.14
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Exposure to noxious gases and particles is associated with an increased prevalence of respiratory and cardiovascular diseases. Thus, investigation of possible airway inflammation and/or systemic inflammation in workers exposed to high levels of dust is important. Silicon Carbide (SiC) Processing Inc. provides cutting fluid (slurry) for the production of solar cells and is at present the largest provider of slurry to the solar industry worldwide. In the production process, the recyclable materials (SiC), polyethylene glycol (PEG)) of the used slurry are recovered. The airborne exposure consists mainly of SiC (dust particles) and evaporation from the recycling of PEG. High levels of dust have been measured and, seventeen per cent of the measurements in the processing hall were equal to or higher than the Norwegian occupational exposure limit. Thus, assessment of possible systemic and airway effects of this exposure is of interest. A prospective design will be applied and the effects studied by means of registration of respiratory symptoms, spirometry, nitric oxide (NO) in exhaled air, induced sputum and blood sampling over a 3 year period. Exposed subjects will also be compare with non- or low exposed subjects (administrative/office workers). Efforts will be made to include all eligible subjects and to avoid drop-outs. If early signs of airway or systemic inflammation in workers or in cells are demonstrated in the study, it will be necessary to implement measures to reduce the exposure levels. The primary aim of the present study of workers exposed to Silicon Carbide dust in the workplace is to determine whether this exposure is associated with inflammatory changes in the lungs. The secondary aims are: - to examine possible changes in systemic inflammatory markers and - to examine changes in lung function among Silicon Carbide processing workers during a period of 3 years. Possible changes in lung function will be monitored by spirometry and gas diffusion measurements (study A). Airway inflammatory responses and changes in circulating inflammatory markers will be assessed by examination of the induced sputum samples and blood samples every 6th month in a subgroup of workers (study B).

Conditions

Obstructive Lung Disease; Inflammation

Keywords

lung function; respiratory symptoms; dust; inflammation; prospective

Study Arms (1)

Main study group

Inclusion criteria: Employment at one of the plants (SiC I) and (SiC II) in Porsgrunn. Both administrative/office workers and workers in the production and maintenance departments will be invited to participate. Non-smokers and smokers and male and female workers will be included in the main study group (study A). Sputum part of study: nonsmokers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Employment at one of the plants (SiC I) and (SiC II) in Porsgrunn. Both administrative/office workers in the production and maintenance departments will be invited to participate. Non- smokers and smokers and male and female workers will be included in the main study group. Only non- smokers will be included in the sputum part of the study.

You may qualify if:

• Employment at SiC plant in Porsgrunn;

You may not qualify if:

• smoking
• active airway infection or less then 3 weeks after recovery
• active allergy

Sponsors & Collaborators

• Sykehuset Telemark: lead
• Oslo University Hospital: collaborator
• National Institute of Occupational Health, Norway: collaborator
• University of North Carolina: collaborator

Study Sites (1)

Sykehuset Telemark

Skien, Telemark, 3710, Norway

Location

Related Publications (12)

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  PMID: 16079062 BACKGROUND

• Bruch J, Rehn B, Song H, Gono E, Malkusch W. Toxicological investigations on silicon carbide. 1. Inhalation studies. Br J Ind Med. 1993 Sep;50(9):797-806. doi: 10.1136/oem.50.9.797.

  PMID: 8398873 BACKGROUND

• Bruch J, Rehn B, Song W, Gono E, Malkusch W. Toxicological investigations on silicon carbide. 2. In vitro cell tests and long term injection tests. Br J Ind Med. 1993 Sep;50(9):807-13. doi: 10.1136/oem.50.9.807.

  PMID: 8398874 BACKGROUND

• Allen M, Butter R, Chandra L, Lettington A, Rushton N. Toxicity of particulate silicon carbide for macrophages, fibroblasts and osteoblast-like cells in vitro. Biomed Mater Eng. 1995;5(3):151-9.

  PMID: 8555965 BACKGROUND

• Fell AK, Sikkeland LI, Svendsen MV, Kongerud J. Airway inflammation in cement production workers. Occup Environ Med. 2010 Jun;67(6):395-400. doi: 10.1136/oem.2009.047852. Epub 2009 Oct 22.

  PMID: 19854695 BACKGROUND

• Toren K, Brisman J, Jarvholm B. Asthma and asthma-like symptoms in adults assessed by questionnaires. A literature review. Chest. 1993 Aug;104(2):600-8. doi: 10.1378/chest.104.2.600.

  PMID: 7802735 BACKGROUND

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.

  PMID: 16204605 BACKGROUND

• Sikkeland LI, Haug T, Stangeland AM, Flatberg G, Sostrand P, Halvorsen B, Kongerud J. Airway inflammation in paper mill workers. J Occup Environ Med. 2007 Oct;49(10):1135-42. doi: 10.1097/JOM.0b013e31814b2e87.

  PMID: 18000418 BACKGROUND

• Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9. doi: 10.1136/thx.47.1.25.

  PMID: 1539140 BACKGROUND

• Sikkeland LI, Kongerud J, Stangeland AM, Haug T, Alexis NE. Macrophage enrichment from induced sputum. Thorax. 2007 Jun;62(6):558-9. doi: 10.1136/thx.2006.073544. No abstract available.

  PMID: 17536036 BACKGROUND

• American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.

  PMID: 15817806 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Induced sputum, serum, citrate- plasma, EDTA-plasma, whole blood and a PaxGene sample for DNA isolation. Cell isolation, RNA isolation and gene expression analysis. Fluid phase analyses.

MeSH Terms

Conditions

Lung Diseases, Obstructive; Inflammation; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Johny Kongerud, professor

  Oslo University; Oslo University Hospital

  STUDY DIRECTOR

• Berit Bakke, PhD

  National Institute of Occupational Health

  PRINCIPAL INVESTIGATOR

• Anne Kristin M Fell, MD

  Sykehuset Telemark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2013-06

Locations

NO (1)